SIMPLOVIR Ganciclovir Ophthalmic Gel 0.15%

Composition  

Each 5 ml vial contains          

Sodium Cromoglycate IP       4% w/v

Benzalkonium chloride NF    0.01% w/v I

(as preservative)         

Sterile Aqueous Base  q.s.

Dosage Form

Ophthalmic Gel

Pharmacology

Simplovir (Ganciclovir ophthalmic gel) 0.15% contains the active ingredient, ganciclovir, which is a guanosine derivative that, upon phosphorylation, inhibits DNA replication by herpes simplex viruses (HSV). Ganciclovir is transformed by viral and cellular thymidine kinases (TK) to ganciclovir triphosphate, which works as an antiviral agent by inhibiting the synthesis of viral DNA in 2 ways: competitive inhibition of viral DNA-polymerase and direct incorporation into viral primer strand DNA, resulting in DNA chain termination and prevention of replication.

Indications

Simplovir (ganciclovir ophthalmic gel) 0.15% is indicated for the treatment of acute herpetic keratitis (dendritic ulcers).

Dosage and Administration

The recommended dosage of Simplovir is 5 times a day for 7 days or as directed by physician.

Contraindications

Simplovir is contraindicated in patients with hypersensitivity to any of the ingredient of the formulation

Warnings & Precautions

For topical ophthalmic use only

Avoidance of Contact Lenses

Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with Simplovir.

Adverse Reactions

Most common adverse reactions reported in patients were blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%).

Pregnancy: Teratogenic Effects There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers It is not known whether topical ophthalmic ganciclovir administration could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when Simplovir is administered to nursing mothers.

Pediatric Use Safety and efficacy in pediatric patients below the age of 2 years have not been established.

Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Storage

Store in a cool & dry place. Protect from light.

Presentation

Simplovir is available in a pack of 5 gm sterile tube.